Press Release

BOULDER, CO – August 4, 2012-- Covidien today announced that it notified customers on July 18, 2012, about a voluntary global recall of certain lots of its Shiley™ reusable cannula, cuffed adult tracheostomy tubes, size 8.This action was in response to reports of volume leakage and/or disconnection between the inner and outer cannulae.

Customers are instructed to return all Shiley 8LPC and 8FEN tracheostomy tubes from the affected lots. If one of the recalled tubes is already in use in a patient, the Company recommends that the tube be replaced as soon as clinically appropriate as determined by the patient’s physician. If the physician advises leaving the tracheostomy tube in place, the Company strongly encourages that the frequency of direct patient observation be increased.

Only certain lots of the size 8 adult, reusable tracheostomy tubes are included in this product recall. All other sizes and styles of Shiley™ tracheostomy tubes are unaffected by this action. These tracheostomy tubes were distributed from October 2009 through June 2012.

Worldwide Product Codes

Product Code

Starting
Lot Number

Ending
Lot Number

8FEN

0910000342

1101001558

8FEN

110201893X

120600700X

8LPC

0910000346

1101001823

8LPC

110200327X

120600351X

This voluntary recall was initiated following an analysis by Covidien of customer reports of volume leakage and/or disconnection between the inner and outer cannula involving these specific tracheostomy tubes. These events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. Volume leakage and/or disconnection could impact ventilation

Covidien has alerted customers by mail of its voluntary recall action and provided instructions on returning the devices. The U.S. Food and Drug Administration and other regulatory bodies have also been notified.
Replacements for the affected lots of product are expected to be available soon. Alternative Covidien products to meet customer needs for the impacted product codes are available.

Adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by phone or fax.